A Study to Evaluate the Skin Irritation Potential of PBI-100 Topical Cream in Healthy Participants

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: PBI-100 Topical Cream; Drug: Positive Control - Sodium laurel sulfate (SLS); Other: PBI-100 Topical Cream, Vehicle; Other: Negative Control

• Registration Number: NCT04882631
• Lead Sponsor: Pyramid Biosciences

Brief Summary

This is an open-label, single-arm, randomized, evaluator-blinded repeat insult patch testing (RIPT) study wherein test product is applied under an occlusive dressing to the upper back or arm continuously and repeatedly to the same site for a period of 21 days.

Detailed Description

This is an open-label, single-arm, randomized, evaluator-blinded repeat insult patch testing (RIPT) study wherein test product is applied under an occlusive dressing to the upper back or arm continuously and repeatedly to the same site for a period of 21 days. Three concentrations of PBI-100 Topical Cream and vehicle (placebo cream) will be applied to the skin of each subject. In addition, one site will be treated with a positive control and another site will be treated with a plain cotton cloth patch and will serve as a negative control.

Study Timeline

• Study Start: 2021-04-12
• Primary Completion: 2021-05-03
• Study Completion: 2021-05-03
• Study First Submitted: 2021-05-06
• Study First Submitted QC: 2021-05-06
• Study First Posted: 2021-05-12
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-25
• Last Update Posted: 2022-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Healthy adult male and female volunteers between the ages of 18 and 70 years with Fitzpatrick types I, II, or III.
• Must be willing to follow the study requirements and voluntarily give their informed consent.
• Subjects must be able to read and follow study instructions in English.
• Generally in good health as determined by the investigator, based on medical history interview.
• Evidence of a personally signed and dated Informed Consent indicating that the subject has been informed of and understood all pertinent aspects of the trial.

Exclusion Criteria

• Scars, moles, or other blemishes over the forearm, upper arm, or back that interfere with the study.
• Sunburn within the last three weeks or use of tanning beds.
• History of allergy or hypersensitivity to skin care or consumer products including fragrances, cosmetics, toiletries, or any kind of tape.
• History of chronic or recurrent dermatological diseases, e.g., psoriasis, atopic eczema, chronic urticaria.
• Subjects receiving systemic or topical drugs which can interfere with the development of an inflammatory response, e.g., steroids, immunosuppressive agents, or retinoids.
• History of any significant systemic diseases e.g., cardiac, pulmonary, renal, hepatic, etc. that would impact subject's ability to complete the study.
• Pregnancy or mothers who are breastfeeding or planning a pregnancy.
• Other conditions considered by the Investigator as sound reasons for disqualification from enrollment into the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cumulative Irritation Test	PBI-100 Topical Cream, Vehicle	Participants will receive topical applications of three concentrations of PBI-100 Topical Cream, one application of vehicle, one application of sodium lauryl sulfate as a positive control and one application of a plain patch as a negative control daily (excluding weekends) for 21 days or 15 applications.
Cumulative Irritation Test	Negative Control	Participants will receive topical applications of three concentrations of PBI-100 Topical Cream, one application of vehicle, one application of sodium lauryl sulfate as a positive control and one application of a plain patch as a negative control daily (excluding weekends) for 21 days or 15 applications.
Cumulative Irritation Test	PBI-100 Topical Cream	Participants will receive topical applications of three concentrations of PBI-100 Topical Cream, one application of vehicle, one application of sodium lauryl sulfate as a positive control and one application of a plain patch as a negative control daily (excluding weekends) for 21 days or 15 applications.
Cumulative Irritation Test	Positive Control - Sodium laurel sulfate (SLS)	Participants will receive topical applications of three concentrations of PBI-100 Topical Cream, one application of vehicle, one application of sodium lauryl sulfate as a positive control and one application of a plain patch as a negative control daily (excluding weekends) for 21 days or 15 applications.

Primary Outcome Measures

Name	Time	Method
Irritation Potential	21 days	Irritation potential based on the Cumulative Irritation Index (CII)

Trial Locations

Locations (1)

KGL Skin Study Center; 🇺🇸 Newtown Square, Pennsylvania, United States